In today's cost-conscious health care environment, health care providers are constantly looking for ways to improve the delivery of quality care to their patients. In instances where the patient requires a specific medical procedure utilizing hand held medical or surgical instruments, these instruments are gathered and sterilized as sets, e.g., tray set-ups, for the patient's specific medical procedure. Thus, for example, a cardiac procedure will have a set, collection or "tray" of instruments, an ophthalmology procedure a different set of instruments, and so forth. Also, for example, different medical specialty departments in the hospital use different instruments. Medical instrumentation or collections of instruments, e.g. trays, today are so specific that often only the particular department which purchased the instrument knows where it goes and what it does. In addition, certain types of medical instrument sets for medical procedures may be organized according to the manufacturer of the instruments or according to the user of the instrument.
The preparation of the tray set ups or operating room trays for invasive medical procedures is a critical function of the medical instrument manager typically, the operating room manager or nurse supervisor. The medical instrument manager must ensure the integrity, sterility, and functionality of the individual instruments as well as the correct organization of sets of instruments into trays for medical procedures. A further responsibility of this person is the inventory and tracking of instruments. Thus it is necessary to be able to identify an inventory of the medical instruments to facilitate, repair and replace the instruments should they become broken or worn.
During a medical or surgical procedure, it is important for the medical personnel to have the correct instruments present, especially correct specialty instruments, placed in the correct trays and also to be able to readily and easily identify and confirm that the proper instruments are indeed present for the medical procedure. For instrument management, it is also important to minimize the number of steps involved in identification and maintenance of the instruments.
In any medical procedure, the instruments require cleaning and sterilization between uses. As is known in the medical arts, the sterilization process typically includes the use of a steam autoclave, rapid sterilization methods, or exposure to chemically active substances. Autoclave manufacturers prepare specific directions for the operation of the autoclave in respect to temperature, time and pressure settings. Typically the autoclave treatment is as follows: Steam treatment under pressure of approximately 30 pounds per square inch(psi) at a temperature of 270.degree. F.(Fahrenheit) for a time period of 50-80 minutes. This time period typically includes a 20-30 minute drying time. A rapid sterilization method requires that the instruments be "flashable". By flashable is meant rapid autoclave sterilization of an instrument using steam treatment under pressure of approximately 30 psi at a temperature of 270.degree. F. for a time period of 3 to 10 minutes depending on the instrument's weight and number of instruments being autoclaved. Alternatively chemical sterilization agents such as CIDEX.RTM. (Johnson & Johnson Company of Racine, Wis.) are used to chemically sterilize medical instruments.
The sterilized sets are delivered to the appropriate operating room, examining room or department where the medical procedure will occur. The rapid sterilization technique is also sometimes used in the operating room when an instrument necessary for a medical procedure falls off of a sterile surface. It is quickly cleaned and rapidly sterilized using the "flashable" sterilization technique previously described, thereby allowing for minimal time interruption in the medical procedure.
After the procedure is completed the instruments are identified, inventoried, cleaned, and examined for needed repair before being sorted into sets and sterilized for subsequent reuse on another patient. The instruments may be jostled against each other after use and prior to the sterilization process, as well as when the instruments are sent out for repair or replacement. Thus it is necessary to be able to identify an inventory of the medical instruments to facilitate, repair and replace the instruments should they become broken or worn.
In the past, color coding schemes for organizing medical or surgical instruments have included applying indicia such as color coding vinyl tapes, dipping the instruments in nylon, TEFLON.RTM. (E. I. DuPont de Nemours & Co., Willmington, Del.) or other plastic dipping solutions, and applying powder coating and colored bonding tapes to the handling surfaces and adjacent areas of the instruments. Each of these methods has drawbacks.
Color coding tapes can be bothersome to surgeons because the tapes roll and stick to surgical gloves. A number of layers of the tape are frequently wound over each other on the medical instrument surfaces sought to be color coded. Further, after repeated washing, decontamination and sterilization, and with normal jostling of instruments, the tape will loosen, tear and fall off. Thus, the instruments require continual retaping, which must be preceded by the labor intensive process of removal of the residual layers of tape and subsequent manual cleaning of the glue residues. The glue on the tape is also of concern because it may harbor harmful bacteria.
Plastic dipping materials such as the nylon TEFLON.RTM. have the advantage of being quite visible; however, the material is too heavy and thick to apply to micro forceps and spring handled instruments and it is nearly impossible to apply to double ended instruments. Also, the plastic dipping materials crack and chip over time and are not "flashable" as described above, because of the nylon or plastic material's heat insulating properties.
In the bonding tape process, tiny color chips are adhered to the instruments with a colorless bonding material. This method suffers from two disadvantages, the chips are very hard to see because they are so small and the chips can peel off if the bonding material is damaged. In addition, the bonding tape is difficult to apply to knurled or ridged surfaces. Plastic dipping materials and colored bonding tapes suffer the additional drawback of being relatively easily removable, especially in the harsh environment to which they are exposed.
In addition to these methods, color coded stainless steel surgical instruments have been introduced onto the market that have paint applied to the handles. The paint application process is not effective because the paint does not bond to the stainless steel surfaces. The paint tends to flake after repeated autoclaving and generally has a very short life span. Also, the painted sets chip upon handling and jostling against other instruments.
Some prior art patents purport to deal with some of the problems created by the use of sticky tape and cracking and peeling coatings on surgical instruments. In U.S. Pat. No. 4,671,916, color coded medical instruments are disclosed which use a colored plug which may have a distinctively shaped bore head. The plug is preferably made of autoclavable material which is inserted in a bore formed in the instrument. The bore into which the plug is secured is 1/32 to 1/4 inch in diameter. The plug may be used to retrofit older instrument sets. However, the color coded plug area is small and requires close scrutiny to identify the instrument as belonging to a particular set.
In U.S. Pat. No. 4,882,867, color coding of a dental instrument is taught where the color coded part is a three dimensional sleeve, ring or disc mounted on a shaft before the formation of a handle by an injection moulding method. This method is not adaptable to retrofit older instrument sets.
U.S. Pat. No. 3,747,603 discloses a surgical kit including a set of cervical dialators having probes of different diameters and handles of identical size and configuration. The handles can be color coded to indicate the probe diameter.
U.S. Pat. No. 3,935,640 discloses a double ended dental instrument with a color coded probe on one end of the instrument. In use, the color coding shows the depth to which the instrument probe has penetrated the periodontal tissue of the mouth.
U.S. Pat. No. 3,840,015 discloses a non-toxic photoluminescent material that is either coated upon a portion of a metallic surgical device, such as an instrument's blade or needle tip, or impregnated within a porous surgical device such as a suturing thread or sponge. With the use of an appropriate exciting light source to illuminate the photoluminescent material, the exact position, relationship and movement of the devices are observed during the medical procedure.
U.S. Pat. No. 3,740,779 shows a surgical scalpel which includes a thermoplastic shaft which is color coded to allow identification of the size and shape of the cutting blade of the instrument.
U.S. Pat. No. 4,253,830 discloses a portable bur block for holding dental burs, using removable elastomeric insert receptacles that may be color coded and arrangeable and rearrangeable in the bur block in an organized manner for ready identification and accessibility of the dental burs.
U.S. Pat. No. 5,275,612 shows the use of color coding a ferrule to signify the type of surgical instrument of which it is a part.
U.S. Pat. No. 4,202,351 discloses an identification means for the ends of lead wires of electrocardiographic monitoring instruments consisting of color coded identification rings having raised indicia which is also color coded to the conventions used in the electrocardiography art to correspond to anatomical locations. The identification ring and raised letters are fabricated or molded of a thermoplastic material with the raised letters forming an integral part of the identification ring but with the raised letters being of a different colored material than the remainder of the ring.
Despite recognition and study of the various aspects of instrument management for hand held medical or surgical instrument identification, the prior art has produced very little in the way of inexpensive, practical techniques for producing a method of identification of sets of instruments by color coding old and new medical or surgical instruments with a permanent color material which is visible under ambient surgical or medical examining room lighting conditions. Nor is there an instrument management system utilizing a color coded system which won't crack or chip off during use, won't impede use by shrinking ring size, and won't leave a sticky tape residue. Additionally, there appears to be problems providing a color coding system which can be applied to knurled, micro and spring type instruments without impeding functionality and which allows for center application for double ended instruments. It is further appreciated that an instrument management system is needed which utilizes a color coding system which can be used on stainless steel, chrome, aluminum or silver plated instruments in a very thin color coded material layer.